Overcoming the Challenges of Dose Uniformity for an Age Appropriate Paediatric Formulation
Posted on April 21, 2016
By:Skylar Wolfea, Research Scientist
Zhihui Gaoa, Dan Tanga, Balvinder Viga, Dolapo Olusanmia, John F. Gambleb, Sailesh Variaa
a Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, NJ USA
b Drug Product Science and Technology, Bristol-Myers Squibb, Moreton, Moreton, Wirral, UK
Abstract A multi-use (up to 60 days) liquid dosage form is being developed for paediatric patients of 1-6 years. The formulation selection process took into account patient driven elements including excipient safety, excipient compatibility with the active pharmaceutical ingredient (API), and palata...
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Related Topics and Keywords
Active Pharmaceutical Ingredient, age approporiate formulations, age appropriate formulations, API, Balvinder Viga, Bristol-Myers Squibb, composition, critical quality attributes, Dan Tanga, Dolapo Olusan, dose uniformity, excipient compatibility, excipient safety, liquid dosage, material characterization, non-standard bulk excipient, paediatric formulation, paediatric patients, palatability, particle characteristics, Skylar Wolfea, sucrose, sweetener grade, Zhihui Gaoa
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